Medical device manufacturing method and medical device assembly

Abstract

A medical device in which a part to be secondarily shaped comprises a molded silicone rubber article is subjected to heatless shaping by irradiation with electron-rays. The irradiation with electron-rays enables shaping and, furthermore, sterilization under some conditions. In a medical device comprising a part in which at least a silicone rubber is used and the mechanical properties of the silicone rubber preferentially appear, the shape of the above-described part upon molding is deformed with the use of a correcting member to a level exceeding the desired deformed shape and maintained in this state. Next, electron-ray irradiation is conducted in this state and then the correcting member is eliminated. Thus, the desired deformed shape intermediate between the shape upon the molding and the shape upon the electron-ray irradiation can be obtained.

1 . A medical device assembly comprising:
 a medical device possessing a predetermined portion comprising silicone rubber, the predetermined portion possessing a first shape and being adapted to be electron beam irradiated to change the first shape of the predetermined portion and cause the predetermined portion to possess a predetermined shape;   a correcting member configured to contact the predetermined portion of the medical device to form a medical device assembly which is subject to the electron beam irradiation, the correcting member being formed of a material which does not stick, adhere or cross-link to the silicone rubber when the correcting member contacts the medical device, the correcting member possessing a shape-giving shape which alters the first shape of the predetermined portion of the medical device when the correcting member contacts the predetermined portion so the predetermined portion of the medical device exhibits a second shape different from the first shape, the correcting member being moved out of contact with the predetermined portion of the medical device after the electron beam irradiation, whereupon the predetermined portion of the medical device possesses the predetermined shape which is different from the first shape and the second shape.   
     
     
         2 . The medical device assembly according to  claim 1 , wherein the silicone rubber has a Shore A hardness of 15 to 80 before electron beam irradiation. 
     
     
         3 . The medical device assembly according to  claim 1 , wherein the correcting member is a shaped wire body or shaped rod body. 
     
     
         4 . A medical device assembly comprising:
 a medical device comprising an electron beam-irradiated predetermined portion made of silicone rubber, the electron beam-irradiated predetermined portion possessing a predetermined bent shape;   a correcting member out of contact with the predetermined portion of the medical device, the correcting member being previously in contact with the predetermined portion of the medical device, the correcting member being made of a material which does not adhere, stick or cross-link to the silicone rubber during contact of the correcting member with the silicone rubber of the predetermined portion even during electron beam irradiation of the correcting member and the silicone rubber, the correcting member which is out of contact with the predetermined portion of the medical device comprising a bending portion which possesses a bent shape that is more bent than the predetermined bent shape.   
     
     
         5 . The medical device assembly according to  claim 4 , wherein the medical device is a tubular member possessing a through hole. 
     
     
         6 . The medical device assembly according to  claim 4 , wherein the bending portion of the correcting member is at one end of the correcting member. 
     
     
         7 . The medical device assembly according to  claim 4 , wherein the correcting member is a shaped wire body or shaped rod body.